This 6 hour virtual seminar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
Why Should You Attend:
This full-day ICH GMP training course will provide your company the opportunity for a comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).
It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.
Agenda: (All time in EDT):
- 10:00 am EDT to 12:00 noon (Agenda Sections I – V below)
- 12:00 noon to 1:00 pm (Lunch)
- 1:00 pm to 3:00 pm (Agenda Sections VI – X below)
- 3:00 to 3:15 pm (Break)
- 3:15 to 4:00 pm (Conclusions and Final Comments)
- 4:00 pm (Q&A Session)